A Clinical Study of JS005 in Patients With Ankylosing Spondylitis
- Conditions
- Ankylosing Spondylitis
- Interventions
- Drug: Recombinant humanized IL-17A Monoclonal Antibody（JS005）Drug: Placebo（JS005）
- Registration Number
- NCT06250062
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
This is a multicentre, randomized, double-blind, parallel, placebo-controlled Phase II clinical study of 261 adults with active ankylosing spondylitis to evaluate the efficacy and safety of JS005 in the treatment of active ankylosing spondylitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 261
- Subjects voluntarily particpate in this clinical study and sign the informed consent form.
- Male and female patients aged 18-75 years at the time of screening (both inclusive)
- Meet the diagnosis of active Ankylosing Spondylitis(AS), have a record of radiological evidence consistent with the Modified New York Classification Criteria for ankylosing spondylitis as revised in 1984 4. Diagnosis of active AS (active AS is defined as: BASDAI >= 4, total back pain score >=4, and BASDAI second question spinal pain score >=4)
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Pregnant or lactating women.
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Active diseases that may confound the evaluation of JS005: other autoimmune inflammatory diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, vasculitis, etc.) or chronic pain other than ankylosing spondylitis (including but not limited to fibromyalgia, osteoarthritis, etc.).
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Active inflammatory bowel disease within 6 months prior to randomization. 5. Recurrent anterior uveitis or acute anterior uveitis within the last 4 weeks prior to randomization.
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History or evidence of active or latent tuberculosis (TB), defined as a positive interferon gamma release assay (IGRA) or purified protein derivative (PPD) at the time of screening. 7. Positive hepatitis B virus test result 8. Prior exposure to JS005 or any other biologic that directly targets IL-17 or the IL-17 receptor.
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use of >= 2 TNF-α inhibitors.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Recombinant humanized IL-17A Monoclonal Antibody（JS005）150mg Placebo（JS005） - Recombinant humanized IL-17A Monoclonal Antibody（JS005）300mg Recombinant humanized IL-17A Monoclonal Antibody（JS005） - Recombinant humanized IL-17A Monoclonal Antibody（JS005）300mg Placebo（JS005） - Placebo（JS005） Placebo（JS005） - Recombinant humanized IL-17A Monoclonal Antibody（JS005）150mg Recombinant humanized IL-17A Monoclonal Antibody（JS005） -
- Primary Outcome Measures
Name Time Method Assessment of SpondyloArthritis International Society criteria (ASAS）40 16 weeks Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）40 response criteria at week 16.
- Secondary Outcome Measures
Name Time Method Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 2.0 16 weeks and 32 weeks The proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) change of 2.0 or greater from baselinat weeks 16 and 32.
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) < 1.3 16 weeks and 32 weeks Proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) less than 1.3 at weeks 16 and 32
Assessment of SpondyloArthritis International Society criteria (ASAS) partial remission 16 weeks and 32 weeks Proportion of subjects who achieved partial remission of Assessment of SpondyloArthritis International Society criteria (ASAS) at weeks 16 and 32
Pharmacokinetic(PK) 40 weeks To evaluate the pharmacokinetic characteristics of JS005: blood concentration of JS005
Immunogenicity 40 weeks The immunogenicity of JS005 was assessed by the positive incidence and titer of drug-resistant antibodies (ADA) and the incidence of neutralizing antibodies (NAb), if applicable
Assessment of SpondyloArthritis International Society criteria (ASAS）40 32 weeks Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）40 response criteria at week 32.
Assessment of SpondyloArthritis International Society criteria (ASAS）20 16 weeks and 32 weeks Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）20 response criteria at weeks 16 and 32.
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) 16 weeks and 32 weeks Changes in ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) from baseline at weeks 16 and 32
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) <2.1 16 weeks and 32 weeks Proportion of subjects with ASDAS-CRP less than 2.1 at weeks 16 and 32.
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 1.1 16 weeks and 32 weeks The proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) change of 1.1 or greater from baselinat weeks 16 and 32.
Trial Locations
- Locations (38)
Beijing Chao-yang Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
Jilin Province People's Hospital
🇨🇳Jilin, Changchun, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, Fujian, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Gansu Provincial Hospital
🇨🇳Lanzhou, Gansu, China
Dongguan People's Hospital
🇨🇳Dongguan, Guangdong, China
Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Zhujiang Hospital of Southren Medical University
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Scroll for more (28 remaining)Beijing Chao-yang Hospital,Capital Medical University🇨🇳Beijing, Beijing, ChinaJuan Meng, PhD.Contact13810582509mserena@163.com